Senior Clinical Research Associate (Sr CRA)
Core
Conduct on-site and remote clinical monitoring visits to assess protocol and regulatory compliance, manage site documentation, and ensure data reliability for pharmaceutical and biotech clinical trials.
Role type
Senior Clinical Research Associate (Sr CRA)
Builds
Clinical trial operations and data integrity for sponsors and CROs
Domain
Life Sciences / Clinical Research / Pharmaceutical
Required skills
Risk-based monitoring, Root cause analysis, ICH-GCP guidelines knowledge, Regulatory compliance, Site management, Data accuracy review (SDR/SDV/CRF), Investigational product inventory, Mentorship
Preferred skills
None stated
Technologies
Clinical Trial Management System (CTMS)
Responsibilities
Monitor investigator sites using risk-based approach; Conduct on-site file reviews and document observations; Mentor junior CRAs; Support study startup and site identification; Ensure audit readiness and regulatory compliance; Track trial status and progress reports.
Seniority
Senior, hands-on IC